Clearance Summary
A.W.E.L. received FDA 510(k) clearance under submission number K943614, sponsored by Medi-Flex. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1995-01-04.
- Submission: K943614
- Applicant / Sponsor: Medi-Flex
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1995-01-04
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.